A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Revatio

• Registration Number: NCT01027117
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief Summary

This will be a randomized, open-label, 3-treatment, 3-period, crossover, single-dose study in healthy subjects. Eighteen (18) subjects will complete the study; dropouts may be replaced at the discretion of the sponsor. Three treatments are:

Treatment A: Revatio 20 mg intact tablet. Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce. Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP). Blood samples for the analysis of sildenafil in plasma will be obtained pre-dose and up to 14 hours post dose in each period. Tolerability and safety will be assessed by reported adverse events during each study period.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Healthy male/female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative.
• Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, ocular or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
• History of febrile illness within 5 days prior to the first dose.
• Any condition possibly affecting drug absorption (eg, gastrectomy).
• A positive urine drug screen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Revatio	Revatio 20 mg intact tablet. This is the reference treatment arm.
Treatment B	Revatio	Treatment B: Revatio 20 mg crushed tablet mixed with apple sauce.
Treatment C	Revatio	Treatment C: Revatio 20 mg extemporaneously prepared suspension (EP).

Primary Outcome Measures

Name	Time	Method
Cmax	Within 14 hours post dose
AUClast	Within 14 hours post dose

Secondary Outcome Measures

Name	Time	Method
Tmax	Within 14 hours post dose
AUCinf	Within 14 hours post dose
T1/2	Within 14 hours post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium